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Clinical Study on the Effect of Tizanidine on the Function and Pain of Patients After Shoulder Arthroscopy

Zhejiang University logo

Zhejiang University

Status and phase

Not yet enrolling
Early Phase 1

Conditions

Rotator Cuff Tears

Treatments

Drug: Celecoxib+Buprenorphine Transdermal Patch
Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

Study type

Interventional

Funder types

Other

Identifiers

NCT05852093
研2023-0251

Details and patient eligibility

About

The perspective, randomized controlled trial is to investigate and evaluate the effect of Tizanidine on the function and pain of patients with rotator cuff tear after shoulder arthroscopy;

Enrollment

100 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1 Patients who were diagnosed as supraspinatus tendon and infraspinatus tendon tear and underwent shoulder arthroscopic surgery in the Second Affiliated Hospital of Zhejiang University; 2 Age 20~70 years old; 3 Those with a long medical history, and symptoms such as shoulder joint pain and weakness in a short period of time are obviously aggravated; 4. After 3 months of medication and physical therapy, the symptoms and functions have not improved significantly; 5 Volunteer to participate in this study, and the person and his/her family members have given informed consent to the content of this study and signed the consent form

Exclusion criteria

  1. Patients with simple frozen shoulder;
  2. Patients with shoulder joint tuberculosis, gout, tumor, rheumatoid disease or infectious disease; 3. There are other joint pain factors before operation;

4 Patients with subscapularis tendon tear, long head tendinopathy requiring surgical treatment, and severe shoulder synovitis were found during the operation; 5 Patients with upper limb nerve injury, shoulder fracture, bone defect or severe osteoporosis; 6. Patients with serious organ or hematopoietic system and other primary diseases; 7. Those who are allergic to the drugs used in this study; 8 Women who are breast-feeding, pregnant or preparing to become pregnant; 9 Patients with language and communication disorders, mental history, cognitive dysfunction, etc. who cannot cooperate with the completion of nursing intervention and research, and cannot complete the questionnaire required for this study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Drug: Celecoxib+Buprenorphine Transdermal Patch
Active Comparator group
Treatment:
Drug: Celecoxib+Buprenorphine Transdermal Patch
Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine
Experimental group
Treatment:
Drug: Celecoxib+Buprenorphine Transdermal Patch+Tizanidine

Trial contacts and locations

0

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Central trial contact

Guang Yang

Data sourced from clinicaltrials.gov

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